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【NMPA】發布熱濕交換器等8項注冊技術審查指導原則的通告

2020-06-17 1404
國家藥監局關于發布熱濕交換器等8項注冊技術審查指導原則的通告(2020年 第39號)
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  為加強醫療器械產品注冊工作的監督和指導,進一步提高注冊審查質量,國家藥監局組織制定了熱濕交換器等8項注冊技術審查指導原則(見附件),現予發布。
特此通告。

  附件:1.熱濕交換器注冊技術審查指導原則
     2.低頻電療儀注冊技術審查指導原則
     3.電動氣壓止血儀注冊技術審查指導原則
     4.肺通氣功能測試產品注冊技術審查指導原則
     5.醫用二氧化碳培養箱注冊技術審查指導原則
     6.沖擊波治療儀注冊技術審查指導原則
     7.熱敷貼(袋)產品注冊技術審查指導原則
     8.聽力計注冊技術審查指導原則

國家藥監局
2020年6月9日

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附件1熱濕交換器注冊技術審查指導原則.doc

附件2低頻電療儀注冊技術審查指導原則.docx

附件3電動氣壓止血儀注冊技術審查指導原則+.docx

附件4肺通氣功能測試產品注冊技術審查指導原則.doc

附件5醫用二氧化碳培養箱注冊技術審查指導原則.doc

附件6沖擊波治療儀注冊技術審查指導原則.docx

附件7熱敷貼(袋)產品注冊技術審查指導原則.docx

附件8聽力計注冊技術審查指導原則.docx

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